Non-interventional Study of COPD Patients With Asthma Overlap Syndrome in Viet Nam and Taiwan

Patients With Asthma-COPD Overlap Syndrome (ACOS) Clinical Trial

Official title:

A Cross-sectional Study to Determine the Proportion and Clinical Characteristics of COPD Patients With Asthma Symptoms in Asia (ACOS) and Describe Current Practices in Diagnosis and Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878252
• Other study ID #: D2287R00106
• Status: Completed
• Start date: October 4, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: April 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study to determine the proportion and clinical characteristics of COPD patients with asthma symptoms (ACOS) and describe current practices in diagnosis and management in Viet Nam and Taiwan.

Description:

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality. Around 15% to 20% of COPD patients would present with features of asthma and are considered to have the overlap syndrome of COPD and asthma, commonly called asthma-COPD overlap syndrome (ACOS). In Asia, specifically Taiwan, the overall prevalence of ACOS in patients with COPD is approximately 17.4%. COPD patients with asthma symptoms represent a relevant clinical population because they have worse health-related quality of life.

Given the increased morbidity among COPD patients with asthma overlap, it is critical that these patients are properly characterized to aid the appropriate diagnosis and treatment. The Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have given joint recommendations on the identification, diagnosis and treatment of these patients. These recommendations have been adapted for use in the Asia Area countries. The primary objective of this study is to determine the proportion and clinical characteristics of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics.

This study is planned to determine the proportion of patients with ACOS as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 28, 2017
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients with confirmed diagnosis of COPD {post-bronchodilator FEV1/FVC<0.7 (FEV1
• forced expiratory volume at one second, FVC - forced vital capacity) based on the medical records}

• Aged >40 years old at time of diagnosis

• Seen at out-patient clinic

Exclusion Criteria:

• Patients currently with acute exacerbation of COPD by GOLD definition (any worsening of a patient's respiratory symptoms that is beyond normal day-to-day variations and requires a change in medication)

• Patients with respiratory diseases that can show similar symptoms to chronic airway diseases such as bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, endobronchial TB, and lung cancer, or those who have history of these diseases based on physician's judgment

• Patients currently diagnosed with pneumonia and acute bronchitis

• Patients currently randomized in other clinical studies

Related Conditions & MeSH terms

• Asthma
• Patients With Asthma-COPD Overlap Syndrome (ACOS)
• Syndrome

Locations

Country	Name	City	State
Taiwan	Research Site	Kaohsing
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Vietnam	Research Site	Ha Noi
Vietnam	Research Site	Ho Chi Minh

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	ASK CRE Private Limited

Countries where clinical trial is conducted

Taiwan,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	medications given to ACOS patients in current practice	To review the medications given to COPD patients with asthma compared to guideline recommendations	6 months
Primary	proportion of ACOS patients among COPD-diagnosed patients seen at the out-patient clinics	To determine the proportion and clinical characteristics of patients with Asthma-COPD Overlap Syndrome (ACOS) as defined by the joint GINA and GOLD recommendation amongst diagnosed COPD patients seen at the out-patient clinic.	6 month
Secondary	symptom control assessment	To review the current practices of symptom control assessment	6 months

External Links

•   CSR Synopsis